About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: January 2012
Anyone attending an FDA Advisory Committee meeting will likely discern right away that the job of serving in the capacity as a member is probably not terribly exciting. You have to travel from where you live, review mountains of data, … Continue reading
As 2011 ended, there was a great deal of looking back at events of the year. As it affected new medical products, FierceBiotech reported on Friday that drug approvals during the year increased to 30 last year. Now as we … Continue reading
It is the first Weekly Roundup of the new year and yet you would not think that to look at the garden where daffodil shoots have already appeared above the soil. A petunia bloomed on the back deck on New … Continue reading
There has been a good deal of commentary on the recent issuance of a draft guidance by the FDA entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which was issued by the agency on … Continue reading